Clinical Research Coordinator II
Clinical Research Coordinator II
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$ 53000 - 61000
1 Vacancy
Job Description
The Department of Medicine Administration is seeking two qualified applicants for a Clinical Research Coordinator II positions as an integral member of the central study management team. This position will participate in all aspects related to coordination of clinical research across multiple specialties working with Division investigators and the team to coordinate clinical studies within the Department. This includes management of multiple research studies with different schedules and deadlines including investigator initiated industry sponsored and government sponsored trials. These trials may be local or multi-centered.
Responsibilities which include but not limited to recruitment of assigned trials interacting with participants within the assigned trials data collection and management AE/SAE reporting scheduling study required procedures and working with Sponsor and CRO for data entry on case report forms or into a computerized database & UF OnCore data system. The ideal candidate will have experience meeting deadlines keen attention to detail protocol requirements sponsor requirements IRB deadlines and comply with the regulatory policies and procedures regarding human subject research.
Essential Functions:
Coordination and Patient Engagement
- Assist Principal Investigator with all study related duties
- Identification and Recruitment of subjects
- Communication with subjects via telephone email and/or in person to gather necessary research information schedule appointments remind subject of protocol requirements and address questions and concerns
- Prepare and compile necessary items for research study appointments
- Schedule subject visits in the Clinical Research Center (CRC) and with other necessary clinic or ancillary offices
- Coordinate with Investigational Pharmacy for study visits requiring study drugs and arrange for orders and dispensing
- Obtaining Informed Consent
- Screening and obtaining accurate and complete medical history
- Documenting and maintaining accurate patient records
- Appropriately assess and document adverse events
- Dispensing Investigational products
- Documenting investigational product accountability
- Monitoring of subjects enrolled in trials in accordance with medical and health management standards study protocols and GCP/ICH guidelines
Study Regulatory Management
- Preparation of documents required for initial submission to UF research offices and for the sponsor.
- Preparing and submitting regulatory documents for revisions and continuing reviews.
- Development of recruitment and advertising materials
- Responsible for preparing reports for the Institutional Review Board in a timely manner
- Development of Informed Consent incorporating UF required language and local regulations into consent templates
- Development of Source Documents
Manage essential regulatory documents - Filing source documents
- Data Entry/ Query Resolution per sponsor guidelines
Financial
- Participate in development of study budgets
- Requesting Cost of Service from Ancillary departments
- Management of study billing plans (including OnCore entry)
- EPIC Charge Review of study subject billing
- Participate with finance team in the tracking and management of study finances including sponsor invoicing and resolving study subject billing issues
- Management of HSP payment tracking and compliance
Other duties as assigned not defined herein but associated with study management and integral to study team.
$53000 - $61000 Annually
Bachelors degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Preferred Qualifications:
Prior experience with clinical research.
Experience with MS Word Excel and data management preferred (InForm REDCap and Oncore)
EPIC EMR System
In order to be considered you must upload your resume.
This requisition has been reposted. If you have already applied for this position re-applying isnt needed at this time.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Required Experience:
IC
Employment Type
Full-Time
